Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Measuring arterial blood volume changes and heart pumping efficiency

Official title: A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery

Run by HemoCept Inc. · NCT07205341 · Data updated 2026-11-12

This pilot will test whether the HemoCept device can detect changes in arterial blood volume and heart pumping efficiency in adults with aortic valve stenosis who are being treated at the participating center.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment20 (estimated)
SponsorHemoCept Inc.
Industry-sponsored
Locations1 site (Boulder, Colorado)
StatusRecruiting
StartedApril 29, 2025
Main results expectedSeptember 2026
Study endsSeptember 2026
Registry record updatedApril 13, 2026
Trial IDNCT07205341 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 to 80 with aortic valve stenosis who are receiving care at the participating facility and require trans-aortic valve replacement, who can provide informed consent and meet study requirements, are ideal candidates.

Probably not a fit

People who are pregnant, breastfeeding, planning pregnancy, or who have a history of long QT syndrome, cardiac channelopathies, or seizures, or who are not undergoing trans-aortic valve replacement at the participating site are unlikely to benefit from this pilot.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot uses the HemoCept device to measure arterial blood volume and indices of cardiac efficiency in adults with aortic valve stenosis who require trans-aortic valve replacement. Participants will be enrolled at a single participating healthcare facility and monitored according to the study protocol before, during, or after valve replacement as specified by investigators. The study seeks to demonstrate the device's ability to detect physiologically meaningful changes rather than to change clinical care. Common exclusions include pregnancy, breastfeeding, and a personal history of long QT syndrome, cardiac channelopathies, or seizures. Consent and HIPAA authorization are required and participants must be treated by the participating site.

Why it matters

Potential benefit: If successful, the HemoCept device could give clinicians a noninvasive way to track arterial blood volume and heart efficiency around valve replacement, potentially improving monitoring and decision-making.

How similar studies have gone: Device-based hemodynamic monitoring approaches have shown promise in research settings, but HemoCept's use for detecting arterial blood volume and cardiac efficiency in this specific patient group is an early, relatively untested pilot.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
* Subjects can be any gender but must be between (and including) the ages of 18 and 80.
* Subject ls being treated by the participating healthcare facility .

  ., Subject requires a trans-aortic valve replacement.
* Subject is able and willing to provide informed consent and HIPM authorization.
* Subject is able and willing to meet all study requirements.

Exclusion Criteria:

* Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
* Subject has a personal medical history that includes:

  * Long O-T syndrome
  * Cardiac channelopathies
  * Seizures

Where it's running

  • Boulder Heart
    Boulder, Colorado, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.